De Faakto Intelligence Research Observatory
Open Source Intelligence Study-Freeze Dried Plasma
Situation
Freeze Dried Plasma
Methodology
OSINT–research
Acronyms
FDP = Freeze Dried Plasma
FFP = Fresh Frozen Plasma
Background
What is Freeze Dried Plasma?
Freeze Dried Plasma (FDP) or Dried Plasma is:
• A yellowish straw colour liquid component of blood separated from donor blood
• FDP contains proteins for blood clotting
• FDP is freeze dried, dehydrated & powdered
• FDP is reconstituted by injecting sterile saline water into a glass bottle containing freeze dried powdered plasma (CTV News, 2017)
What is Fresh Frozen Plasma?
• Fresh Frozen Plasma is made from plasma which is separated from donor blood and frozen at -35 degrees centigrade to preserve it
• Fresh Frozen Plasma is then stored as frozen packs at -18 degrees centigrade until needed
• FFP is thawed at 37 degrees centigrade in a warm water bath and takes approximately 30 minutes to thaw
• FFP must be used within 24 hours or discarded (NHS, 2016)
How does Plasma work?
• In trauma with massive haemorrhage patients lose blood-[containing plasma, platelets & red blood cells]
• The plasma component of blood contains critical proteins necessary for clotting that controls & stops bleeding
• Traditional trauma resuscitation uses non blood fluids called IV crystalloids and red blood cells, followed by administration of plasma and platelets
• This method successfully treats most trauma victims with mild or moderate injuries
• Military and civilian researchers have found that individuals with massive bleeding benefit when they received plasma at the same ratio as red blood cells (facs.org, 2015)
History of Freeze Dried Plasma
• U.S. forces used freeze-dried plasma in World War II, but quit in 1968 after it was linked to hepatitis outbreaks, in the years since, the safety testing of it improved and for years militaries have used FDP
• Single donor FDP was introduced in 2007 which significantly reduced the risk of transmitted infection, transforming FDP into a safer product
• Army Special Operations medics saw it in use and said they wanted it too
• The U.S. military currently gets its supply from the French, whose plasma is made from volunteer donors
• FDP has a shelf life of about two years (CTV News, 2017)
Where is Freeze Dried Plasma Available?
• France
• Germany
• South Africa
• Norway
• Other unspecified countries (onlinelibrary.wiley.com, 2016)
• FDP is not yet approved in the United States by the Food & Drug Administration
• U.S. Special Forces troops initially started using FDP with special permission under investigational treatment from the Food & Drug Administration (FDA)
• Now all branches of the U.S. Military is carrying FDP
• Israeli Defence forces use FDP
When is Freeze Dried Plasma used?
• Freeze dried plasma is used when traditional plasma treatments are indicated (haemorrhage) but not available due to the logistics of storing FFP, which would include austere & remote conditions, military combat applications or multiple casualty incidents
What are the advantages FDP?
• FDP enhances clot formation and attenuates hyperfibrinolysis better than normal saline and albumin and is a potential alternative to plasma resuscitation in the treatment of hemorrhagic shock (onlinelibrary.wiley.com, 2016)
• FDP does not require thawing-FFP must be thawed prior to use and has a limited shelf life of 24 hours
• Studies have demonstrated that the thawing process of FFP can cause protein aggregation and
degradation
• FDP stores easily overcoming freezer storage logistics
• FDP offers greater stability and tolerance to ambient temperature
• It can be stored until it is reconstituted and administered with minimal protein degradation
• The use of dried plasma would avert the product waste of FFP as it is quickly reconstituted when needed
• FDP Reconstitutes in 2-5 minutes unlike fresh frozen plasma which takes 30 minutes (Defense Health Board, 2011)
• FDP is optimum for austere conditions-remote, at sea, rural hospitals
• FDP for Surge capacity for multiple casualty incidents when FFP supplies depleted
• Favourable for aeromedical evacuations (Defense Health Board, 2011)
• FDP can be strategically stockpiled for disasters and emergencies
Why is Freeze Dried Plasma beneficial to haemorrhaging soldiers?
• During trauma-in military or civilian-remote or austere settings, it may be impossible to move patients to hospital facilities within the first few hours of injury
• Freeze-dried plasma fills a pre-hospital capability gap in damage control resuscitation (U.S. Army Medical Command, 2016)
• FDP enhances clot formation and attenuates hyperfibrinolysis better than NS and albumin and is a potential alternative to plasma resuscitation in the treatment of hemorrhagic shock
• FDP potentially enhances clot formation and resists breakdown better than normal saline (NS) and albumin and similar to liquid plasma (onlinelibrary.wiley.com, 2016)
• Over the past five years, the military’s special ops units in the Army, Navy, Air Force and Marines have received about 1,000 kits of the freeze-dried plasma, including 430 this year. While specific numbers on usage are scarce, the U.S. Special Operations Command said it had been used at least 24 times by Green Berets and other special operations teams in the past five years. Of those treatments, 15 patients survived long enough to be transferred to a hospital (CTV News, 2017)
What are the other benefits of Freeze Dried Plasma?
• FDP is more stable then fresh frozen plasma (FFP)
• FDP is tolerant to ambient temperature
• Cold chain requirements are eliminated because freezing is not required during shipment or storage
• FDP exhibits minimal protein degradation during storage
• FFP once thawed expires within 24 hours-Using FDP avoids FFP waste
• FFP process may cause protein aggregation & degradation-FDP does not have this problem (Defense Health Board, 2011)
Are there any disadvantages to Freeze Dried Plasma?
• FDP comes in glass bottles, breakage is a possibility and glass containers may be considered heavy
• FDP can be stored at room temperature in the short term; however stockpiles are stored by the U.S. Military at 2-6 degrees centigrade for extended times (healthline.com, 2018)
How will Freeze Dried Plasma likely be used in the future?
• Early and aggressive use of plasma in pre-hospital [damage control resuscitation]
• Rural medicine
• Austere conditions-sea, remote, delayed transport, aeromedical medevac
• Surge capacity multi casualty incidents
• When the supply of conventional plasma becomes depleted (CTV News, 2017)
Analysis & Recommendations
Freeze Dried Plasma used by the U.S. Military exhibited benefits in combat trauma as early as WW2. Unfortunately early FDP products were discontinued by the U.S. military in 1968 due to concerns of hepatitis transmission. Since that time better donor screening programs have mitigated infection transmission risk. FDP is currently used in France, Germany, South Africa, Norway and other unspecified countries. Military medics have embraced FDP because of the benefits of plasma trauma resuscitation and the superior logistics for portability and long term storage with minimal degradation. FDP plasma overcomes the logistics problems of freezer storage and waste created by Fresh Frozen Plasma. FDP is faster to treatment time because reconstitution takes 2-5 minutes as opposed to the 30 minutes required to thaw FFP. Agencies using FFP plasma for emergency trauma resuscitation should consider augmenting FDP as it becomes available. This will optimize efficiency during the trauma golden hour, and saves money by avoiding the expense of freezer facilities, shorter shelf life and waste created by FFP. FDP is easily stockpiled in comparison to Fresh Frozen Plasma. Freeze Dried Plasma is practical for cases of field trauma, long ambulance transport times and trauma/surgical inter facility transports.
Resources
U.S. troops get freeze-dried plasma for battlefield bloodshed-CTVnews.ca (2017) https://www.ctvnews.ca/health/u-s-troops-get-freeze-dried-plasma-for-battlefield-bloodshed-1.3700614
Fresh Frozen Plasma (FFP) and Cryoprecipitate Patient information-NHS blood & transplant (2016) http://hospital.blood.co.uk/media/28440/160602-27456-ffp-and-cryoprecipitate-final.pdf
New Rapid-Deployment Plasma Protocol for Trauma Care Effectively Treats Patients Quicker in the Emergency Room-American College of Surgeons-facs.org (2015) https://www.facs.org/media/press-releases/2015/trauma0515
Dried plasma: state of the science and recent developments-onlinelibrary.wiley.com (2016) https://onlinelibrary.wiley.com/doi/pdf/10.1111/trf.13580
Use of Dried Plasma in Prehospital Battlefield Resuscitation-Defense Health Board (2011) https://webcache.googleusercontent.com/search?q=cache:kFcABE_YRkEJ:https://health.mil/Reference-Center/Reports/2011/08/08/Use-of-Dried-Plasma-in-Prehospital-Battlefield-Resuscitation+&cd=15&hl=en&ct=clnk&gl=ca
USAMMDA and Freeze-Dried Plasma: A Story of Success-U.S. Army (2016) https://www.army.mil/article/174904/usammda_and_freeze_dried_plasma_a_story_of_success
How Freeze-Dried Plasma Saves Soldiers’ Lives-Healthline (2018) https://www.healthline.com/health-news/freeze-dried-plasma-saves-soldiers-lives#1
Disclaimer-De Faakto Intelligence Research is provided to first responders for situational awareness, advice, guidance and educational purposes. Intelligence is perishable and fluid. Intelligence is updated and reassessed as new information becomes available. Sources are evidence based and multiple sources are used when possible. Sometimes intelligence assessments present gaps in information, this is a reality in intelligence led operations and gaps are filled when information presents. Emergency first responders should always follow best industry practices, organizational policy-procedures and regulatory standards.
